Approved drug

An approved drug is a preparation that has been validated for a therapeutic use by a ruling authority of a government.

In the United States, the FDA approves drugs. Before a drug can be prescribed, it must undergo the FDA's approval process. Drug companies seeking to sell a drug in the United States must first test it. The company then sends the Center for Drug Evaluation and Research (CDER)[1] evidence from these tests to prove the drug is safe and effective for its intended use. A team of CDER physicians, statisticians, chemists, pharmacologists, and other scientists reviews the company's data and proposed labeling. If this independent and unbiased review establishes that a drug's health benefits outweigh its known risks, the drug is approved for sale. The center doesn't actually test drugs itself, although it does conduct limited research in the areas of drug quality, safety, and effectiveness standards.